With EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR), the related changes will impact existing registered medical devices, especially IFU and labels. This documentread more...
Philippines FDA adopts the WHO Collaborative Registration Procedure (CRP) for the Accelerated Registration of WHO Prequalified Pharmaceutical Products and Vaccines.
This Administrative Order is issued to establish an accelerated review process for prequalified pharmaceutical products and vaccines, through the adoption of the WHO CRP into the national registration procedures andread more...
Thailand FDA issued an Announcement on Regulations, Procedures and Conditions for Providing Academic Documents for Medical Devices
The announcement was issued to confirm the standards of quality, efficacy and safety for medical devices for review by or for submission to the authorities upon request and to protectread more...
The Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act (abbreviation is “Advanced Regeneration Bio Act.”) and the subordinate Enforcement Decree became effective as of 28 August 2020.
The Therapeutic Goods Administration (TGA) has launched a new initiative – the Early Scientific Advice service – that enables applicants to request scientific advice on specific data before they applyread more...
On October 10, 2020, NMPA made an announcement in relation for Drug Information Traceability System for key drug products (Circular No. 2020/111)
Marketing authorization holders (MAHs) take the main responsibility forread more...
All applicants who submit applications to obtain import licenses
for medicines in Sri Lanka should submit the application along with the following price details with effect from 31st of August 2020
China Releases Technical Guidance for Using Real-World Evidence(RWE) to Support R&D and Regulatory Review of Pediatric Drugs (Interim)
The CDE has issued this guidance to assist researchers in understanding the application of real-world evidence in the R&D and clinical trials concerning pediatric drugs.
The CDE previously published “Guiding Principlesread more...
The changes are with the consideration of the ICH E6(R2), key changes are:
Article 23: sponsor’s subsidies and payments provided to subjects;
Article 30: qualifications and abilities of the investigator
Article 37: responsibilities